Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients With Infective Endocarditis

Infective Endocarditis Clinical Trial

— REMOVE  

Official title:

Revealing Mechanisms and Investigating Efficacy of Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients With Infective Endocarditis - a Multicentric Randomized Controlled Group Sequential Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03266302
• Other study ID #: ZKSJ0108
• Status: Completed
• Phase: N/A
• Start date: January 17, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2020
• Source: Jena University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Infective endocarditis (IE) is associated with high hospital mortality for various reasons; one of them is circulatory failure in patients who undergo cardiac surgery for IE. One discussed reason underlying circulatory failure during surgery is the release of vasodilatatory mediators and cytokines. This study examines the efficacy and safety of a hemoadsorption filter which is approved for the reduction of the concentration of cytokines in the bloodstream.

Description:

The investigators assume a common standard deviation of 3.8 points and that a 1.4-point lower SOFA score in the Intervention Group is of clinical relevance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: December 31, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with infective endocarditis (according to DUKE criteria) undergoing cardiac surgery

• informed consent

• age =18 years

Exclusion Criteria:

• EuroScoreII = 3

• current participation in another interventional Trial

• pregnancy

• current immunosuppressive or immunomodulatory therapy (with dosing of glucocorticoids over Cushing threshold)

• previous participation in the REMOVE study

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis

Intervention

Device:
• hemoadsorber for removal of cytokines
Use of the hemoadsorber during cardiac surgery with CPB. Hemoadsorber is integrated into the CPB circuit according to manufacturer's recommendation.

Locations

Country	Name	City	State
Germany	University Heart Center Bad Krozingen	Bad Krozingen	Baden-Württemberg
Germany	Herz- und Diabeteszentrum NRW, Klinik für Thorax- und Kardiovaskularchirurgie	Bad Oeynhausen
Germany	Herzzentrum Brandenburg, Immanuel Klinikum Bernau	Bernau bei Berlin
Germany	Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH, Klinik für Herz- und Thoraxchirurgie	Bochum
Germany	Universitätsklinikum Bonn, Klinik und Poliklinik für Herzchirurgie	Bonn
Germany	University Hospital Cologne, Clinic and Policlinics for Heart and Thoracic Surgery	Cologne	North Rhine-Westphalia
Germany	Herzzentrum Dresden GmbH, Universitätsklinik an der TU Dresden, Klinik für Herzchirurgie	Dresden
Germany	Universitätsklinikum Düsseldorf, Klinik für Kardiovaskuläre Chirurgie	Düsseldorf
Germany	University Hospital Essen, Clinic of Thoracic and Cardiovascular Surgery	Essen	North Rhine-Westphalia
Germany	University Heart Center Freiburg	Freiburg	Baden-Württemberg
Germany	Mitteldeutsches Herzzentrum, Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Herzchirurgie	Halle (Saale)
Germany	Jena University Hospital, Dept. of Cardiac and Thoracic Surgery	Jena	Thuringia
Germany	Herzzentrum Leipzig, Universitätsklinik für Herzchirurgie	Leipzig
Germany	University Hospital Ulm, Clinics of Heart-, Thoracic and Cardiovascular Surgery	Ulm	Baden-Württemberg

Sponsors (5)

Lead Sponsor	Collaborator
Jena University Hospital	CytoSorbents, Inc, Fraunhofer Institute for Interfacial Engineering and Biotechnology, German Federal Ministry of Education and Research, Thermo Fisher Scientific

Country where clinical trial is conducted

Germany, 

References & Publications (7)

Bernardi MH, Rinoesl H, Dragosits K, Ristl R, Hoffelner F, Opfermann P, Lamm C, Preißing F, Wiedemann D, Hiesmayr MJ, Spittler A. Effect of hemoadsorption during cardiopulmonary bypass surgery - a blinded, randomized, controlled pilot study using a novel adsorbent. Crit Care. 2016 Apr 9;20:96. doi: 10.1186/s13054-016-1270-0. — View Citation

Boyle EM Jr, Pohlman TH, Johnson MC, Verrier ED. Endothelial cell injury in cardiovascular surgery: the systemic inflammatory response. Ann Thorac Surg. 1997 Jan;63(1):277-84. Review. — View Citation

Brunkhorst FM, Oppert M, Marx G, Bloos F, Ludewig K, Putensen C, Nierhaus A, Jaschinski U, Meier-Hellmann A, Weyland A, Gründling M, Moerer O, Riessen R, Seibel A, Ragaller M, Büchler MW, John S, Bach F, Spies C, Reill L, Fritz H, Kiehntopf M, Kuhnt E, Bogatsch H, Engel C, Loeffler M, Kollef MH, Reinhart K, Welte T; German Study Group Competence Network Sepsis (SepNet). Effect of empirical treatment with moxifloxacin and meropenem vs meropenem on sepsis-related organ dysfunction in patients with severe sepsis: a randomized trial. JAMA. 2012 Jun 13;307(22):2390-9. doi: 10.1001/jama.2012.5833. — View Citation

Bustamante J, Arévalo A, Tamayo E, Sarria C, Aguilar-Blanco EM, Heredia M, Almansa R, Rico L, Iglesias V, Bermejo-Martin JF. Cytokine profiles linked to fatal outcome in infective prosthetic valve endocarditis. APMIS. 2014 Jun;122(6):526-9. doi: 10.1111/apm.12189. Epub 2013 Sep 30. — View Citation

Hotchkiss RS, Karl IE. The pathophysiology and treatment of sepsis. N Engl J Med. 2003 Jan 9;348(2):138-50. Review. — View Citation

Minne L, Abu-Hanna A, de Jonge E. Evaluation of SOFA-based models for predicting mortality in the ICU: A systematic review. Crit Care. 2008;12(6):R161. doi: 10.1186/cc7160. Epub 2008 Dec 17. Review. — View Citation

Prendergast BD, Tornos P. Surgery for infective endocarditis: who and when? Circulation. 2010 Mar 9;121(9):1141-52. doi: 10.1161/CIRCULATIONAHA.108.773598. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SOFA Score	The investigators will test if mean SOFA scores are different for the experimental and control group.	24 hours before until day 9 post-surgery
Secondary	Overall mortality rate	Overall mortality rate until day 30 post-surgery	until day 30 post surgery
Secondary	Changes in cytokine and cfDNA levels	changes in cytokine and cfDNA levels will be measured at different time points before, during and after surgery in both groups; only for the first 2x25 patients	24 hours before, during cardiac surgery and 24 hours after surgery
Secondary	SOFA subscores	single SOFA subscores will be analyzed	24 hours before surgery until day 9 post-surgery
Secondary	Days on ventilator, vasopressor and renal replacement therapy	Total days on ventilator, vasopressor and renal replacement therapy within 30 days post-surgery will be assessed	until day 30 post-surgery
Secondary	incidence of stroke	incidence of stroke within 30 days post-surgery will be assessed	until day 30 post-surgery
Secondary	length of ICU and in-hospital stay	total length of ICU and in-hospital stay until day 30 post-surgery	until day 30 post-surgery